A Phase 1/2 interventional study of Fisetin and Placebo in Multimorbidity and Healthy, sponsored by Ove Andersen. Recruiting at 1 site in Denmark. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Ove Andersen · Phase 1/2, Interventional, and Treatment
The accumulation of senescent cells with age is a central mechanism that contributes to the development of chronic diseases, primarily by driving systemic chronic inflammation. Senolytic compounds such as fisetin can selectively target senescent cells for elimination and reduce multiple age-related pathologies in animal models.
We will conduct a clinical trial in healthy volunteers and older patients with multiple chronic diseases. The participants will receive fisetin or placebo for two days, after which they will be examined at regular intervals for up to three months. We will investigate how fisetin is absorbed and metabolized by the body, and whether fisetin is safe. We will also identify methods to best measure the effect of fisetin on chronic inflammation, senescent cells, and general health.
The goal of this pilot trial is to conduct a controlled clinical study to gather data on the pharmacokinetic profile of fisetin and its metabolites and on the safety and tolerability of fisetin in healthy volunteers as well as in older medical patients. Furthermore, we aim to identify potential outcome measures and perform sample size calculations for these outcomes, with the intent to conduct a larger scale effect study, at later date, given the result from this pilot study suggests that this would be feasible and safe.
The trial consists of:
a 2-arm triple-blind randomized placebo-controlled study, in which older medical patients (n=40) will receive either:
Each of the studies (open-label study and randomized placebo-controlled study) consists of three sub-studies:
Ove Andersen is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy volunteers:
Inclusion Criteria:
Exclusion Criteria:
Older patients with multimorbidity:
Inclusion Criteria:
At screening #1 during hospital admission:
At screening #2 28 days after hospital discharge:
Exclusion Criteria:
At screening #1 during hospital admission:
At screening #2 28 days after hospital discharge:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers will receive fisetin.
Drug: Fisetin
Older patients with multimorbidity will receive fisetin.
Drug: Fisetin
Older patients with multimorbidity will receive placebo.
Drug: Placebo
Subjects will receive fisetin corresponding to 20 mg/kg/day for two consecutive days.
Subjects will receive a corresponding number of placebo capsules for two consecutive days.
Population-based pharmacokinetic model for fisetin and metabolites
To develop a population-based pharmacokinetic (popPK) model for fisetin and its main metabolites in healthy volunteers and older patients, covariates such as body weight, body composition, age, and CYP inducers/inhibitors will be tested for influence on interindividual variability.
Time frame: 24 hours
Adverse events
Number of participants to experience adverse events
Time frame: Day 1 to 3
suPAR
The change in plasma levels of suPAR and a sample size calculation based on these data.
Time frame: Day 1 to 29
Population-based PKPD model for fisetin
Changes in any of the measured biomarkers and the relationship between the pharmacokinetics and pharmacodynamics of fisetin will be investigated using population PKPD modeling.
Time frame: 24 hours
Renal excretion of fisetin and its main metabolites
Urinary levels of fisetin and its main metabolites
Time frame: 24 hours
Symptoms and adverse events
Number of participants to experience symptoms and clinically significant changes in vital signs (i.e., blood pressure, pulse).
Time frame: Day 1 to 3
SASP factors and inflammation markers
The change in plasma levels of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors).
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Senescence
The change in expression levels of senescence markers (e.g., p16INK4a, p21CIP1/WAF1, SA-B-gal) in immune cells and tissue biopsies (skin and adipose tissue).
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 8, 15, 29, 84.
Senolysis
The change in expression levels of senolysis markers (e.g., leukotriene B4, dihomo-15d-PGJ2 (oxylipin or 1a,1b-dihomo-15-deoxy-D12,14-prostaglandin J2), and 15-Deoxy-delta 12, 14-prostaglandin J2).
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 84.
Aging markers
The change in plasma levels of aging markers (e.g., α-klotho, fibroblast growth factor 21).
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Clinical markers
The change in levels of routine biochemistry markers (e.g., alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, coagulation factors II, VII and X and International Normalized Ratio, CRP, creatinine, hemoglobin, lactate dehydrogenase, mean corpuscular hemoglobin concentration, mean corpuscular volume, neutrophils, potassium, sodium, thrombocytes, white blood cell count, cholesterol (total, low-density lipoproteins, high-density lipoproteins), triglycerides, and hemoglobin A1c).
Time frame: Healthy volunteers: day 1, 2, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Frailty Index OutRef
The change in frailty status calculated as Frailty Index OutREF (FI-OutRef).
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Frailty Index
The change in frailty status calculated using a modified version of Fried frailty criteria.
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 2, 8, 15, 29, 57, 84.
Physical function
The change in physical function (e.g., gait speed, hand grip strength, chair stand test, balance).
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Cognitive function (Montreal Cogntive Assessment)
The change in cognitive function assessed using the MoCA score (0-30 with higher scores representing better cognitive function).
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Cognitive function (Digit Symbol Substitution Test)
The change in cognitive function assessed using the Digit Symbol Substitution Test (number of correct symbols).
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Quality of life
The change in quality of life assessed using the EuroQol-5D-5L (index value and VAS scale 0-100; with higher scores representing better quality of life).
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Self-rated health
The change in self-rated health (score 1-5; 1:"excellent", 2:"very good", 3:"good", 4:"fair", or 5:"bad").
Time frame: Healthy volunteers: day 1, 29. Older patients: day 1, 29, 84.
Plan to share: No — Only aggregated data can be available for other researchers due to Danish Data Protection Law.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2028, 33 months after the start.
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Studies of the drug tested here: Fisetin
Ove Andersen